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Impact of New Cancer Vaccine to be Evaluated in Rochester

September 19, 2007

Rochester has been chosen as one of four national sites to monitor the effectiveness of the new cervical cancer vaccine. The project, which is funded by the national Centers for Disease Control and Prevention (CDC), will be jointly conducted by the University of Rochester Medical Center (URMC) and the New York State Department of Health.

“Rochester has a strong history of coming together as a community to evaluate new vaccines and improve vaccination rates,” said Nancy M. Bennett, M.D., M.S., director of the URMCCenter for Community Health. “This study is critical because many of the fundamental questions about a new vaccine cannot really be answered until we have been able to look at its impact on a broad population over a long period of time.”

The study is part of a CDC-led effort in cooperation with Emerging Infections Programs (EIP) based in state health departments and academic medical centers to evaluate the adoption and impact of the new human papillomaviruses (HPV) vaccine. “Specifically, the study is an attempt to determine how many people are receiving the vaccine and whether or not it is having a measurable impact on rates of cervical cancer and its precursor lesions,” said Dale L. Morse, M.D., M.S., director of the Office of Science and Public Health, New York State Department of Health and the director of the New York State EIP.

Two new HPV vaccines are currently being brought to market. Merck’s vaccine – Gardasil – was approved federal Food and Drug Administration earlier this year and GlaxoSmithKline’s Cervarix is expected to be endorsed by the agency later this year. The CDC recommends that the vaccine should be routinely given to girls at 11-12 years of age.

In the United States, more than 15,000 people every day, or about 5.5 million people a year, get sexually transmitted HPV infections from their partners. About three out of every four sexually active people will get an HPV infection at some point during their lifetime. Most people fight off the virus and never even know they were infected. Others have warts or abnormal cell growth known as dysplasias. In the most serious cases, it progresses to cervical cancer; there are 9,700 new cases of cervical cancer in women in the United States every year. Two types of HPV, type 16 and type 18, cause about 70 percent of cervical cancers, and those are the types that the new vaccine is designed to prevent.

The Rochester team will create a consortium of Ob/Gyn physicians from the region’s three health systems and pathologists from the three laboratories that process all of the pap smears and cervical biopsies in MonroeCounty. The study will look at a subset of test results that indicate a more acute and invasive form of dysplasia. Researchers will combine this data with vaccination rates to see how rapidly the new vaccine is being taken up in the community and whether or not individuals diagnosed with acute dysplasia were vaccinated.

By tracking the incidence of precancerous dysplasia, rather than the cancer rates themselves, researchers will be able to more rapidly assess the impact of the vaccine. Dysplasia can take years to evolve into active cervical cancer, if at all, and the new vaccine is being administered to young women who are not yet sexually active. Even so, researchers anticipate that this effort will span several years.

The study is a homecoming of sorts for Rochester. Much of the underlying research that led to the development of the vaccine began more than 20 years ago in the labs of URMC virologists William Bonnez, M.D., Richard Reichman, M.D., and Robert Rose, Ph.D.

Rochester is also home to considerable expertise in vaccine surveillance. The University of Rochester is a member of the New York State Emerging Infections Program that is part of a 10-site national surveillance and research network of state health departments funded by the CDC. That network tracks several diseases and performs studies of the effectiveness of new vaccines after they’ve been licensed. The University is also part of a three-site network, the New Vaccine Surveillance Network, run by CDC that evaluates the impact of new vaccines and vaccine policies.